11.040.55 诊断设备 标准查询与下载
共找到 856 条与 诊断设备 相关的标准，共 58 页
IEC 80601-2-49:2018 applies to basic safety and essential performance requirements of multifunction patient monitors, hereafter referred to as ME equipment or medical electrical systems. This particular standard applies to multifunction patient monitors intended for use in professional healthcare facilities as well as in the emergency medical service environment or the home healthcare environment. The scope of this document is restricted to ME equipment or medical electrical systems intended for connection to a single patient that has two or more physiological monitoring units. For purposes of this document, a pregnant mother and her fetus(es) are considered a single patient. This document does not specify requirements for individual physiological monitoring units such as ECG, invasive pressure and pulse oximetry. The particular standards related to these physiological monitoring units specify requirements from the perspective of stand-alone ME equipment. This particular standard addresses the additional requirements related to multifunction patient monitors. Multifunction patient monitors can be integrated into other ME equipment or medical electrical systems. When this is the case, other relevant standards also apply. This document does not apply to implantable parts of multifunction patient monitors. This first edition cancels and replaces the second edition of IEC 60601-2-49, published in 2011. This edition constitutes a technical revision to align with the current edition and Amendment to IEC 60601-1, new versions of collateral standards and amendments thereto. Major changes are in Clause 208 because many of the former requirements are now addressed by IEC 60601-1-8.
Medical electrical equipment - Part 2-49: Particular requirements for the basic safety and essential performance of multifunction patient monitors
- ICS
- 11.040.55
- CCS
- 发布
- 2021-07-01
- 实施
ISO 80601-2-56:2017 applies to the basic safety and essential performance of a clinical thermometer in combination with its accessories, hereafter referred to as me equipment. This document specifies the general and technical requirements for electrical clinical thermometers. This document applies to all electrical clinical thermometers that are used for measuring the body temperature of patients. Clinical thermometers can be equipped with interfaces to accommodate secondary indicators, printing equipment, and other auxiliary equipment to create me systems. This document does not apply to auxiliary equipment. Me equipment that measures a body temperature is inside the scope of this document. ISO 80601-2-56:2017 does not specify the requirements for screening thermographs intended to be used for the individual non-invasive human febrile temperature screening of groups of individual humans under indoor environmental conditions, which are given in IEC 80601‑2‑59[4]. If a clause or subclause is specifically intended to be applicable to me equipment only, or to me systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to me equipment and to me systems, as relevant. Hazards inherent in the intended physiological function of me equipment or me systems within the scope of this document are not covered by specific requirements in this document except in IEC 60601‑1:2005+A1:2012, 7.2.13 and 8.4.1. NOTE Additional information can be found in IEC 60601?1:2005+A1:2012, 4.2.
Medical electrical equipment — Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
- ICS
- 11.040.55
- CCS
- 发布
- 2021-07-01
- 实施
ISO/TS 18339:2015 specifies the design of eyepiece cap and light guide connector of an endoscope to enable the combination of products from different manufacturers. The products intended only for limited combination are out of the scope. It is a mechanical connection; it might not generate best results, but it allows the user to be able to work. ISO/TS 18339:2015 supports manufacturers of components in the design of interfaces.
Endotherapy devices — Eyepiece cap and light guide connector
- ICS
- 11.040.55
- CCS
- 发布
- 2021-07-01
- 实施
Good refurbishment practices for medical imaging equipment
- ICS
- 11.040.55
- CCS
- 发布
- 2021-06-28
- 实施
Good refurbishment practices for medical imaging equipment
- ICS
- 11.040.55
- CCS
- 发布
- 2021-06-28
- 实施
Methods for calculating size specific dose estimates(SSDE) for computed tomography
- ICS
- 11.040.55
- CCS
- 发布
- 2021-06-28
- 实施
Good refurbishment practices for medical imaging equipment
- ICS
- 11.040.55
- CCS
- 发布
- 2021-06-28
- 实施
Methods for calculating size specific dose estimates(SSDE) for computed tomography
- ICS
- 11.040.55
- CCS
- 发布
- 2021-06-28
- 实施
Medical electrical equipment — Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
- ICS
- 11.040.55
- CCS
- 发布
- 2021-06-28
- 实施
Good refurbishment practices for medical imaging equipment
- ICS
- 11.040.55
- CCS
- 发布
- 2021-06-28
- 实施
Methods for calculating size specific dose estimates(SSDE) for computed tomography
- ICS
- 11.040.55
- CCS
- 发布
- 2021-06-28
- 实施
Medical electrical equipment — Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
- ICS
- 11.040.55
- CCS
- 发布
- 2021-06-28
- 实施
Methods for calculating size specific dose estimates(SSDE) for computed tomography
- ICS
- 11.040.55
- CCS
- 发布
- 2021-06-28
- 实施
Endoscopes. Medical endoscopes and endotherapy devices. Particular requirements for capsule endoscopes
- ICS
- 11.040.55
- CCS
- 发布
- 2021-05-18
- 实施
- 2021-05-18
本文件提出了临床诊断中多层螺旋CT诊断辐射剂量参考水平（diagnostic reference levels, DRL）。
Diagnostic reference levels of CT radiation dose
- ICS
- 11.040.55
- CCS
- Q841
- 发布
- 2021-03-27
- 实施
- 2021-08-06
本文件规定了颈动脉磁共振管壁成像的接收线圈、磁共振成像、诊断报告的质量控制要求。
Requirements for quality control of carotid magnetic resonance vessel wall imaging
- ICS
- 11.040.55
- CCS
- C43
- 发布
- 2021-03-27
- 实施
- 2021-06-01
Medical electrical equipment Part 2-33: Specific requirements for basic safety and basic performance of magnetic resonance equipment for medical diagnosis
- ICS
- 11.040.55
- CCS
- C43
- 发布
- 2021-03-09
- 实施
- 2023-05-01
Medical electrical equipment Part 2-40: Special requirements for basic safety and basic performance of myoelectric and induced response equipment
- ICS
- 11.040.55
- CCS
- C39
- 发布
- 2021-03-09
- 实施
- 2023-05-01
Medical electrical equipment Part 2-20: Specific requirements for basic safety and essential performance of infant transport incubators
- ICS
- 11.040.55
- CCS
- C39
- 发布
- 2021-03-09
- 实施
- 2023-05-01
Ultrasonics - Transducers - Definitions and measurement methods regarding focusing for the transmitted fields
- ICS
- 11.040.55
- CCS
- 发布
- 2021-02-05
- 实施
- 2021-03-17
